Kedrion Biopharma Inc. announced that it has established the framework for a long-term agreement with Biotest AG for the full commercialization and distribution of the immunoglobulin therapy Yimmugo® in the U.S., following its Biologic License Application (BLA) approval by the U.S. Food and Drug Administration (FDA) on June 13, 2024. Immunoglobulin therapies, such as Yimmugo, are essential in managing primary immunodeficiencies (PID), which affect approximately 500,000 people in the U.S. They play a crucial role in preventing infections, enhancing immune function, and improving the quality of life for patients. As Kedrion currently distributes two of the fastest-growing injectable immunoglobulin (IG) therapies in the U.S., the company is well-positioned for successful commercialization and distribution of Yimmugo®.

Subject to finalizing the definitive long-term agreement, Biotest is expected to begin supplying Yimmugo® to Kedrion in Fourth Quarter 2024, with a market launch planned for Quarter one 2025. The U.S. IG market is expected to grow by roughly 9% per year in the next eight years, representing an increasing patient need for the product. Distributing Yimmugo® allows Kedrion to remain at the forefront of meeting this market need and reaching a greater portion of the PID patient population.

Yimmugo® is produced using a state-of-the-art process at Biotest's new FDA-certified "Next Level" production facility in Dreieich, Germany. The modern production process aims to achieve high product quality and promotes a responsible use of resources. Yimmugo® is a polyvalent immunoglobulin G preparation from human blood plasma for intravenous administration (IVIg) for the treatment of primary humoral deficiency (PID) in patients 2 years of age or older.

Yimmugo® is the first approved product from the new Biotest Next Level production facility.